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Gauri Patel

Karmic Lifesciences Consulting Services, India

Biography

Gauri Patel brings in over 10 years’ experience in Clinical Research. She is a Certified SQA [RQAP-GCP; RQAP-GLP] Professional. She has over 10 years of Quality Assurance experience, dealing with Quality Monitoring of procedures to ensure regulatory compliance for clinical, bio-analytical, and statistical phases of clinical trials and facing regulatory inspections. With a firm understanding of allover (GMP, GCP+GLP) applicable guidelines and regulations, her core strength areas are compliance assessment (monitoring; auditing; inspecting) and applied expertise (evaluation and advisory, remediation) towards achieving regulatory compliance. During later part of her career, she has been a Speaker at various forums and has conducted quite a few GxP workshops for industry. Prior to Karmic Lifesciences, she has worked in Quality Assurance for Cliantha Research Ltd., and additionally, was instrumental in pioneering and establishing training systems for the organization.

Abstract

Abstract : Role-play of GxP standards in growth of Indian pharmaceutical industry: Recent trends in GCP and GLP requirements